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Advanced Gastric CancerPhase 2NCT03137004

Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

A Phase 2 study testing Docetaxel and S-1 in people with Advanced Gastric Cancer, run by Fujian Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as second-line treatment in patients with AGC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Docetaxel and S-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
1 Jun 2017to 10 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-75 years old;
  • Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
  • The patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy without taxanes for metastatic disease.
  • Relapse within 6 months after adjuvant chemotherapy;
  • ECOG (Eastern Cooperative Oncology Group)performance status 0-2;
  • At least 1 measurable lesion should be present（RECIST1.1）
Show all 9Show fewer
  • Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN
  • Signed informed consent.
  • Life expectancy ≥3 months;

Who cannot join

  • Previous treatment with taxanes (not including intraperitoneal use of taxanes);
  • Known history of hypersensitivity to study drugs;
  • Active CNS metastases not controllable with radiotherapy or corticosteroids;
  • Pregnant or breast feeding women;
  • Severe co-morbid illness and/or active infections;
  • Active and uncontrollable bleeding from gastrointestinal tract
Show all 9Show fewer
  • Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol;
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);
  • Known HIV infecton.

Trial locations and contacts

1 site in 1 country.

Rongbo Lin, MD contact

008613705919382

rongbo_lin@163.com

JIE LIU, MD contact

008613860632919

dr2868@sina.com

China1 site

  • Rongbo Lin

    Fuzhou, Fujian, 350014

Other trials in China

About this study

Official title: A Single-arm Phase II Trial of Biweekly Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as second-line treatment in patients with AGC.

Read the detailed description

For patients with advanced gastric cancer, combination chemotherapy has been shown to improve the quality of life and overall survival (OS) compared with best supportive care alone. Docetaxel is an active agent for treating patients with gastric cancer. S-1, an oral 5-FU prodrug, is active against AGC as a single agent or in combination with cisplatin in phase III trials. Therefore, a single-arm phase II study was conducted to investigate the efficacy and safety of biweekly docetaxel and S-1 (DS) combination therapy as second-line treatment in patients with previously treated advanced gastric cancer.

Being tested
Docetaxel, S-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel 50mg/m2 in 60 min on day 1 and repeated every 14 days.

  • S-1Drug

    Also called TS-1

    S-1 was administered orally at 40 mg/m2 twice daily on days 1-7 of each cycle. Patients with a body surface area of less than 1.25 m2 received 80 mg S-1 daily, those with a body surface area of 1.25 m2 or more but less than 1.5 m2 received 100 mg S-1 daily, and those with a body surface area of 1.5 m2 or more received 120 mg S-1 daily.

Study groups in NCT03137004
Study groupRoleWhat they receive
biweekly DSExperimentalThe biweekly DS regimen consisted of Docetaxel (50mg/m2) and S-1 (40mg/m2)
Receives: Drug: Docetaxel; Drug: S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. six-month overall survival

    Measured: 6 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Measured: 6 months

  2. Overall Survival (OS)

    Measured: 12 months

  3. Progression-Free Survival (PFS)

    Measured: 12 months

  4. Adverse Event（AE）

    Measured: NCI CTC 4.03

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2017
  2. Study start1 Jun 2017 (estimated)
  3. Primary completion10 Apr 2018 (estimated)
  4. Study completion10 Oct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03137004
Sponsor's protocol ID
FNF-005
Status last verified
May 2017
First submitted
27 Apr 2017
Last updated
8 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and S-1 in people with Advanced Gastric Cancer, run by Fujian Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rongbo Lin, MD (008613705919382, rongbo_lin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

six-month overall survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03137004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.

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